A "Very Good Year" for Roche

Roche today reported a 2% year-to-year increase in profits (1% at constant exchange rates), helped by rising demand for cancer drugs and diagnostic tests, as well as strong sales in the U.S. and emerging markets.

“2012 was a very good year for Roche. We met our financial targets, grew faster than the market, and our strong pipeline positions us well for further growth,” CEO Severin Schwan said in a statement.

Roche said the promising numbers reflected in part launches of three new cancer drugs. Zelboraf® for BRAF V600 mutation-positive metastatic melanoma rang up its first sales in Europe last year, more than doubling the drug’s sales to CHF 234 million ($255.6 million). “Zelboraf performed well in Western Europe and the United States as a result of higher-than-expected BRAF testing rates. The growth rate of Zelboraf reflects the high unmet need in metastatic melanoma,” Roche said in the statement.

Also launched last year in the U.S. and Switzerland were Perjeta for women with HER2-positive breast cancer, used in combination with Roche’s Herceptin and chemotherapy. Perjeta generated CHF 56 million ($61.2 million) in sales last year, all but CHF 2 million ($2.2 million) of that racked up in the U.S.

That number should grow this year since Roche received a positive opinion for Perjeta at the end of 2012 from the European Medicines Agency’s Committee for Medicinal Products for Human Use or CHMP. Roche anticipates launching the drug in Europe in Q1 2013.

Roche’s third cancer drug launch last year was Erivedge for advanced basal cell carcinoma. Erivedge finished the year with CHF 29 million ($31.7 million) in sales, reflecting nearly a full year since the drug was launched in the U.S. in February 2012.

The company’s pharmaceutical division sales grew at the same 7% as Roche overall, to CHF 35.2 billion ($38.5 billion), though only 4% at CER. The diagnostics division, by contrast, rose 5% (4% CER) to CHF 10.3 billion ($11.2 billion) led by a 15% jump in its immunoassay business, though profits dipped 2% to CHF 2.2 billion ($2.4 billion) due to pressure to contain prices on diabetes care drugs.

For 2013, Roche is counting on sales from a planned launch this year of T-DM1 (trastuzumab emtansine), an antibody-drug conjugate for patients with HER2-positive metastatic breast cancer. T-DM1 consists of trastuzumab, the active ingredient in Herceptin, the chemotherapy agent DM1, and a linker that joins DM1 to trastuzumab. The drug is designed to target and inhibit HER2 signalling and deliver DM1 directly inside HER2-positive cancer cells.

Following promising overall survival data in the EMILIA Phase III trial—namely extending the lives of patients by 5.8 months in the second-line setting—Roche has filed for approvals to market T-DM1 in Europe and the U.S., where the treatment has been granted priority review in the U.S.